Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns With Lupus (NCT00007358) | Clinical Trial Compass
CompletedNot Applicable
Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns With Lupus
United States150 participantsStarted 2000-10
Plain-language summary
Some newborns are born with congenital heart block (CHB), a condition occurring in babies with neonatal lupus. The first part of the study will test the effectiveness of fluorinated steroids, including dexamethasone, in improving the heart function and general health of newborns who have auto-antibody-associated CHB. The second part of this study will use ultrasound and heart monitoring to observe high-risk pregnant women and their fetuses during the third trimester of pregnancy.
Who can participate
Age range
16 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for Prospective Part of Trial:
* Mother must have anti-Ro and/or anti-La antibody
* Fetal bradyarrhythmia (slow, abnormal heart rhythm)
Exclusion Criteria for Prospective Part of Trial:
* Fetal heart abnormalities that may cause newborn CHB and could account for atrioventricular (AV) block
Inclusion Criteria for Observational Part of Trial:
* Mother must have anti-Ro and/or anti-La antibody
* Fetus must have documented normal heartbeat prior to the 16th week of pregnancy
* Fetus must have a structurally normal heart
* Mother must be enrolled during the 16th, 17th, or 18th week of pregnancy
Exclusion Criteria for Observational Part of Trial:
* Mother is taking more than 10 mg of prednisone per day
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.